Three former Food and Drug Administration leaders expressed concern about staffing reductions at the agency during a presentation at the STAT Summit on Wednesday. Robert Califf, who served as FDA commissioner under Presidents Obama and Biden, characterized a major initiative involving government workforce cuts as historically significant in negative terms. The cuts, which removed 3,500 workers, were followed by additional departures under former FDA Commissioner Marty Makary, who left his position in May. A White House official has been nominated as a replacement but has not yet undergone Senate confirmation proceedings.
Scott Gottlieb and Ned Sharpless, both of whom held FDA leadership positions during the first Trump administration, joined Califf in discussing the impact of the personnel changes. Sharpless described the reductions as arbitrary, while Gottlieb noted that pharmaceutical and device companies now frequently interact with less experienced regulatory staff. The former officials emphasized that losing experienced personnel means the loss of accumulated institutional knowledge that cannot be quickly replaced.
The panelists acknowledged some positive developments, including departures of certain high-ranking officials they did not identify by name. They expressed confidence in the current acting commissioner and policy leadership, saying the agency appears to be refocusing on regulatory fundamentals. However, they cautioned that recovery will require time and a renewed commitment to workforce retention and protection from political interference.
The former commissioners also addressed broader challenges facing federal health agencies, including public confidence issues related to vaccine communication during recent years and current policy debates. They advised that the FDA should concentrate on its core statutory responsibilities related to drug and medical device safety and effectiveness rather than attempting to address peripheral policy matters like drug pricing or vaccine hesitancy.
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